Catheter with an asymmetric tip

ABSTRACT

A catheter may include a catheter body, which may include a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body that extends between the proximal end and the distal end along a longitudinal axis. The distal end of the catheter body may include a distal lumen opening disposed on the longitudinal axis. The distal end may also include a leading edge. The leading edge may form the distal lumen opening and may include an upper and a lower portion. The lower portion of the leading edge may be disposed distally to the upper portion of the leading edge.

BACKGROUND OF THE INVENTION

The present invention relates generally to vascular access systems andcomponents, including catheter assemblies and devices used with catheterassemblies. In particular, the present invention relates to systems andmethods for improving a catheter tip to provide improved insertion,infusion flow rates, and fluid collection.

Vascular access devices are used for communicating fluid with theanatomy of a patient. For example, vascular access devices, such ascatheters, are commonly used for blood sampling. Blood sampling is acommon health care procedure involving the withdrawal of at least asample of blood from a patient. Once collected, blood samples areanalyzed via one or more blood test levels.

Vascular access devices are also commonly used for infusing fluid, suchas saline solution, various medicaments, and/or total parenteralnutrition, into a patient, withdrawing blood from a patient, and/ormonitoring various parameters of the patient's vascular system. Avariety of clinical circumstances, including massive trauma, majorsurgical procedures, massive burns, and certain disease states, such aspancreatitis and diabetic ketoacidosis, can produce profound circulatoryvolume depletion. This depletion can be caused either from actual bloodloss or from internal fluid imbalance. In these clinical settings, it isfrequently necessary to infuse blood and/or other fluid rapidly into apatient to avert serious consequences.

In order to properly place a catheter vascular access device in apatient, the catheter is typically mounted over an introducer needlehaving a sharp distal tip. At least the distal portion of the cathetertightly engages the outer surface of the needle to prevent peel back ofthe catheter and thus facilitates insertion of the catheter into theblood vessel. The tip of the needle preferably extends beyond the tip ofthe catheter with the bevel of the needle facing up towards thepatient's skin.

The catheter and needle are inserted at a shallow angle through thepatient's skin into the blood vessel. In order to verify properplacement of the catheter and the needle in the blood vessel, theclinician may confirm that there is flashback of blood in a flashbackchamber. The flashback chamber may typically be formed as part of theneedle hub. Once proper placement of the catheter and needle assemblyinto the blood vessel is confirmed, the clinician applies pressure tothe blood vessel by pressing down on the patient's skin over the bloodvessel distal of the needle and the catheter. This finger pressureoccludes or at least minimizes further blood flow through the needle andthe catheter. The clinician then withdraws the needle, leaving thecatheter in place for use in accordance with standard medical technique.

In some instances, an opening in a distal tip of the catheter may be atleast partially obstructed or blocked by an inner wall of the bloodvessel when the catheter is placed in the blood vessel. Obstruction ofthe opening in the tip of the catheter may restrict flow through thecatheter, inhibiting fluid infusion and/or blood collection. In someinstances, obstruction of the opening in the tip of the catheter andflow restriction through the catheter may also result in bloodhemolysis, which may decrease a quality of a blood sample and mayrequire additional samples to be taken.

BRIEF SUMMARY OF THE INVENTION

In some embodiments, the present invention is directed to a vascularaccess device that may provide for more efficient infusion and bloodcollection procedures, as well as collection of high quality bloodsamples. Thus, in some embodiments, the vascular access device may beconfigured to be used in combination with a vascular infusion systemand/or a blood collection system. In some embodiments, the vascularaccess device may also provide improved insertion of a needle andcatheter assembly. The vascular access device generally includes anintravenous catheter configured to access the vascular system of apatient.

In some embodiments, a catheter body of the intravenous catheterincludes a proximal end, a distal end, and a lumen formed by an innerwall of the catheter body that extends between the proximal end and thedistal end of the catheter body along a longitudinal axis. In someembodiments, the distal end may include a distal lumen opening disposedon the longitudinal axis. The term “leading edge” as used in the presentdisclosure may refer to an edge of the catheter body that forms thedistal lumen opening and contacts the needle when the needle is in aninsertion configuration. In some embodiments, the leading edge mayinclude a distal-most surface of the catheter body. In some embodiments,the leading edge may include an upper portion and a lower portion. Insome embodiments, the upper portion of the leading edge may be disposedcloser to skin of a patient than the lower portion of the leading edgeafter the peripheral catheter is placed within a vein of the patient.

In some embodiments, the lower portion of the leading edge may bedisposed distally to the upper portion of the leading edge. In these andother embodiments, the leading edge may be beveled between the upperportion and the lower portion of the leading edge. In some embodiments,an outer wall of the catheter body may include a tapered portion and anuntapered portion. In some embodiments, the tapered portion may bedisposed at least proximate the leading edge. In some embodiments, thetapered portion may taper inwardly at an angle between 2 and 30 degreeswith respect to the longitudinal axis. In some embodiments, the taperedportion may be asymmetric. For example, a proximal end of a lower sideof the tapered portion may be disposed distally to a proximal end of anupper side of the tapered portion. The term “symmetric” as used in thepresent disclosure may include symmetry about an axis or axisymmetry.The term “asymmetric” as used in the present disclosure may includeasymmetry about an axis or non-axisymmetry.

In some embodiments, the tapered portion may include one or more flowholes. For example, an upper side of the tapered portion may include asingle flow hole. In some embodiments, at least one third of a length ofthe upper side of the tapered portion may include the single hole.

In some embodiments, each of the flow holes may be in communication withthe lumen and may include a passageway with an inner wall surfacedefining a first plane. In some embodiments, an orientation of the firstplane to the longitudinal axis may be acute. For example, theorientation of the first plane to the longitudinal axis may be fortyfive degrees.

In some embodiments, an inner wall of the catheter body may include aland portion at least proximate the leading edge. The land portion maybe configured to contact the needle when the needle is inserted in theperipheral catheter. In some embodiments, one or more of the flow holesmay include a passageway that extends through the land portion. In someembodiments, the land portion may be asymmetric. For example, a proximalend of one side of the land portion may be offset from a proximal end ofan opposite side of the land portion, such that the two proximal endsare not diametrically opposed. In further detail, in some embodiments,the proximal end of the one side of the land portion may be distal tothe proximal end of the opposite side of the land portion. In these andother embodiments, a cross-section of the land portion may be configuredin a shape of a parallelogram.

In some embodiments, an inner wall of the catheter body may include ashoulder proximate to the land portion. In some embodiments, a portionof the inner wall corresponding to an upper edge of the shoulder may beangled with respect to the longitudinal axis and/or a portion of theinner wall corresponding to a lower edge of the shoulder may be angledwith respect to the longitudinal axis. In some embodiments, the shouldermay be asymmetric. In some embodiments, the angle of the upper edge ofthe shoulder may be a same angle or a different angle as the angle ofthe lower edge of the shoulder.

In some embodiments, the distal end of the catheter body may include anexternal geometry defined by an outer wall of the distal end and aninner geometry defined by the inner wall of the distal end. In someembodiments, the distal end of the catheter body may be asymmetric. Forexample, the external geometry and/or the inner geometry of the catheterbody may be asymmetric. Examples of an asymmetric distal end may includea distal end that includes one or more of the following: the lowerportion of the leading edge disposed distally to the upper portion ofthe leading edge, a beveled leading edge between the upper and the lowerportion of the leading edge, an asymmetric land portion, an asymmetricshoulder, an asymmetric tapered portion, etc. An asymmetric distal endmay provide several advantages, as will be explained in further detail.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of an example peripheral intravenouscatheter, according to some embodiments;

FIG. 2 is a longitudinal cross-sectional view of a portion of an examplecatheter that includes an asymmetric outer geometry and an asymmetricinner geometry, according to some embodiments;

FIG. 3A is a longitudinal cross-sectional view of the portion of thecatheter of FIG. 2 coupled with an example introducer needle in aninsertion configuration, according to some embodiments;

FIG. 3B is a longitudinal cross-sectional view of a portion of anotherexample catheter with a symmetric outer geometry and a symmetric innergeometry, coupled with the introducer needle in the insertionconfiguration, according to some embodiments;

FIG. 4A is a longitudinal cross-sectional view of the catheter of FIG.3B being used for infusing a fluid into a patient, according to someembodiments;

FIG. 4B is a longitudinal cross-sectional view of the catheter of FIG. 2being used for infusing a fluid into a patient, according to someembodiments;

FIG. 5A is a longitudinal cross-sectional view of the catheter of FIG.3B being used for blood collection from the patient, according to someembodiments;

FIG. 5B is a longitudinal cross-sectional view of the catheter of FIG. 2being used for blood collection from the patient, according to someembodiments;

FIG. 6 is longitudinal cross-sectional view of a portion of anotherexample catheter that includes an asymmetric outer geometry and asymmetric inner geometry, according to some embodiments;

FIG. 7 is a side view of the catheter of FIG. 2 or 6, according to someembodiments;

FIG. 8 is an upper perspective view of the catheter of FIG. 2 or 6,according to some embodiments;

FIG. 9 is a cross-sectional view of the catheter of FIG. 2 or 6,according to some embodiments;

FIG. 10 is a cross-sectional view of a portion of another examplecatheter, according to some embodiments;

FIG. 11A is an upper perspective view of a portion of another examplecatheter coupled with an example introducer needle, according to someembodiments;

FIG. 11B is a side view of another portion of the catheter of FIG. 11Acoupled with the introducer needle, according to some embodiments;

FIG. 12A is an upper perspective view of a portion of another examplecatheter coupled with an example introducer needle, according to someembodiments;

FIG. 12B is a side view of the portion of the catheter of FIG. 12Acoupled with the introducer needle, according to some embodiments;

FIG. 12C is a cross-sectional view of the portion of the catheter ofFIG. 12A coupled with the introducer needle, according to someembodiments;

FIG. 13A is an upper perspective view of a portion of another examplecatheter coupled with an example introducer needle, according to someembodiments;

FIG. 13B is a side view of the portion of the catheter of FIG. 13Acoupled with the introducer needle, according to some embodiments;

FIG. 14 is a side view of a portion of another example catheter coupledwith an example introducer needle, according to some embodiments; and

FIG. 15 is a cross-sectional view of a portion of another examplecatheter, according to some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “proximal” may refer to a location with respectto the device that, after a catheter assembly is inserted into a patientduring normal use, is closest to the clinician and farthest from thepatient. Conversely, the term “distal” may refer to a location withrespect to the device that, after the catheter assembly is inserted intothe patient during normal use, is farthest from the clinician andclosest to the patient. As used herein, the term “top,” “up,” “upper,”or “upwardly” refers to a location with respect to the device that,after the catheter assembly is inserted into the patient during normaluse, is radially away from the longitudinal axis of the device andtoward the patient's skin. Conversely, as used herein, the term“bottom,” “lower,” “down,” or “downwardly” refers to a location withrespect to the device that, after the catheter assembly is inserted intothe patient during normal use, is radially away from the longitudinalaxis of the device and away from the patient's skin.

Embodiments of the present invention will be best understood byreference to the drawings, wherein like reference numbers indicateidentical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Referring now to FIG. 1, a vascular access device may include aperipheral intravenous catheter 10 (referred to in the presentdisclosure as “PIVC 10”). Although this invention is described herein inconnection with a PIVC, it is to be understood that this invention isapplicable to other catheters and vascular access devices. For someapplications, the vascular access device is inserted into a peripheralvein of the patient. In other applications, the vascular access deviceis inserted into a central vein of the patient.

In some embodiments, the PIVC 10 may include a short or truncatedcatheter 12 (usually 13 mm to 52 mm) that is inserted into a smallperipheral vein. For example, the PIVC 10 may include a diameter ofapproximately a 14 gauge catheter or smaller. However, the catheter 12may be any length, where the length is selected based on the intendedapplication of the catheter 12. The catheter 12 may also include anydiameter, where the diameter is selected based on the intendedapplication of the catheter 12.

In some embodiments, the introducer needle 16 may typically be insertedthrough the catheter 12 such that a sharp distal tip of the needleextends beyond a tip 13 of the catheter 12. Once the catheter 12 isinserted into the blood vessel 15 of the patient, the introducer needle16 may be removed from an inner lumen of the catheter 12 to permitinfusion and/or blood collection via the catheter 12.

Suitable materials for the catheter 12 may include, but are not limitedto, thermoplastic resins such as fluorinated ethylene propylene (FEP),polytetrafluoroethylene (PTFE), polyurethane, and the like. In someembodiments, the catheter 12 may be formed from a thermoplastichydrophilic polyurethane that softens with exposure to physiologicalconditions present in the patient's body. The catheter 12 may include aflexible or semi-flexible biocompatible material, as commonly used inthe art. In other embodiments, the catheter 12 may include a metallicmaterial, such as surgical steel, titanium, cobalt steel, and the like.Additionally, in some embodiments, the material used to form thecatheter 12 may be transparent or at least translucent. Additionally, insome embodiments, the catheter 12 may be formed so that it is partiallytransparent or translucent such as where catheter 12 is formed fromstripes of transparent or translucent material. This may allow theclinician to see blood flashback in an annular space between theintroducer needle 16 and the catheter 12 where the introducer needle 16includes a notch, i.e. a hole or opening in the sidewall, adjacent to adistal end of the introducer needle 16 to allow such blood flow.

In some embodiments, the PIVC 10 may include a catheter adapter 18 thatmay house a proximal end of the catheter 12. Suitable materials for thecatheter adapter 18 may include, but are not limited to, thermoplasticpolymeric resins such as polycarbonate, polystyrene, polypropylene, polyethylene phthalate glycol (PETG) and the like. In some embodiments, thematerial used to form the catheter adapter 18 may be transparent or atleast translucent to allow the clinician to view blood flashbacktherein.

In some embodiments, the catheter adapter 18 may include a port 20 thatis coupled with an extension tube 22. In some embodiments, the extensiontube 22 may be coupled to upstream infusion and/or blood collectioncomponents. In some embodiments, the extension tube 22 may betranslucent to allow the clinician to view flashback of blood therein toconfirm successful venipuncture. In some embodiments, the extension tube22 may be integrated with the catheter adapter 18, as described, forexample, in further detail in U.S. Pat. No. 5,697,614.

In some embodiments, an inner lumen of the catheter adapter 18 may be influid communication with both an inner lumen of the extension tube 22and the inner lumen of the catheter 12. In some embodiments, a tip ofthe introducer needle 16 may be defined by a bevel, and a proximal endof the introducer needle 16 may be connected to a needle hub 24. In someembodiments, the introducer needle 16 may be formed from stainless steeland may have a longitudinal axis that is generally parallel to alongitudinal axis of catheter 12 and/or the PIVC 10.

In some embodiments, the introducer needle 16 may be formed with a notchadjacent to the distal end of the introducer needle 16. Thisconfiguration may allow blood to flow into the open tip of theintroducer needle 16 and then out of the notch into the annular spacebetween the catheter 12 and the introducer needle 16. If the catheter 12is at least translucent, the clinician may be able to observe bloodflashback promptly upon successful venipuncture. Additionally, in someembodiments, when the blood flows into the extension tube 22, ifextension tube 22 is at least translucent, the clinician may also beable to observe blood flashback in the extension tube 22. In someembodiments, where no notch is formed in the introducer needle 16, theneedle hub 24 may include an integrated flashback chamber having an openproximal end that is closed to fluid flow by a vented plug that mayallow air but not fluid to flow there through. The needle hub 24 may beformed from the same types of materials that are used to form thecatheter adapter 18. Of course, other materials may be used to form theneedle hub 24.

The catheter 12 of the PIVC 10 in accordance with the present inventionmay include a distal end or tip 13. The tip 13 may include an externalgeometry defined by an outer wall of the tip 13 and an inner geometrydefined by an inner wall of the tip 13. In some embodiments, the tip 13may be asymmetric. For example, the external geometry and/or the innergeometry of the tip 13 may be asymmetric. An asymmetric externalgeometry of the tip 13 and/or an asymmetric internal geometry of the tip13 may provide several advantages, as will be explained in furtherdetail.

Referring now to FIG. 2, a side view in cross section of the tip 14 ofthe catheter 12 is illustrated, according to some embodiments. In someembodiments, the tip 14 may correspond to the tip 13 of FIG. 1. In someembodiments, the tip 14 may include a central lumen 26 formed by theinner wall 28 of the tip 14. In some embodiments, the central lumen 26may extend along a longitudinal axis 30 of the catheter 12 and maydefine a fluid flow path from a leading edge 32 of the tip 14 through toa proximal end of the catheter 12. In some embodiments, the leading edge32 may include a width and a planar surface normal to the longitudinalaxis 30 of the catheter 12, as illustrated in FIG. 2.

In some embodiments, the outer wall 34 may include an untapered portion36 and/or a tapered portion 38. In some embodiments, the untaperedportion 36 may be parallel to the longitudinal axis 30. In someembodiments, the tapered portion 38 may be proximal to the leading edge32 and distal to the untapered portion 36. In some embodiments, thetapered portion 38 may taper inwardly at an angle of between about 10and 45 degrees with respect to the longitudinal axis 30. In someembodiments, the tapered portion 38 may be terminated by the leadingedge 32. In some embodiments, the tapered portion 38 may taper linearlyinwardly towards the leading edge 32.

In some embodiments, the outer geometry of the tip 14 may be asymmetric,as illustrated in FIG. 2. For example, the proximal end 40 a of one sideof the tapered portion 38 may be offset from a proximal end 40 b of anopposite side of the tapered portion 38, such that the two proximal ends40 a, 40 b are not diametrically opposed. In some embodiments, theproximal end 40 b, which may be disposed on a lower side of the taperedportion 38, may be disposed distally to the proximal end 40 a, which maybe disposed on an upper side of the tapered portion 38.

Additionally or alternatively, in some embodiments, upper and lowerportions 42 a, 42 b of the leading edge 32, disposed on opposite sidesof the tip 14, may be offset such that the upper and the lower portions42 a, 42 b are not diametrically opposed, and the leading edge 32 isbeveled. In some embodiments, the upper portion 42 a may include anupper-most portion of the leading edge 32, and the lower portion 42 bmay include a lowest portion of the leading edge 32. In someembodiments, the lower portion 42 b of the leading edge 32 may bedisposed distally to the upper portion 42 a of the leading edge 32. Theleading edge 32 may be beveled between the upper and lower portions 42a, 42 b at various angles, such as for example, between 20 and 80degrees with respect to the longitudinal axis 30. This angle is shown at“A” on FIG. 2.

The asymmetric outer geometry of the tip 14 may improve insertionperformance of the catheter 12. For example, in some embodiments, theasymmetric outer geometry may provide a smooth and more gradualtransition from a smaller profile of the introducer needle 16 to alarger profile of the tip 14 outer diameter. The asymmetric outergeometry of the tip 14 may also reduce a penetration force necessary topenetrate the skin and/or the blood vessel 15 of the patient with thevascular access device. In some embodiments, the asymmetric outergeometry may reduce a force spike felt by the clinician as the tip 14 isinserted in the skin and/or the blood vessel 15 of the patient,providing a smoother insertion experience. Further, in some embodiments,because the leading edge 32 is beveled between the upper and lowerportions 42 a, 42 b and the tip of the introducer needle 16 is alsobeveled, the tip 14 may be easily fit or be inserted into a shape of anopening in the blood vessel 15 of the patient created by the tip of theintroducer needle 16 when the introducer needle 16 and the catheter 12are placed in the blood vessel 15 of the patient, also providing asmoother insertion experience. A particular asymmetric outer geometrythat includes leading edge 32 that is beveled between the upper portion42 a and the lower portion 42 b may facilitate threading or advancing ofthe catheter 12 while retracting the introducer needle 16.

Referring now to FIG. 3A, in some embodiments, the introducer needle 16may include a primary bevel 80 and/or a secondary bevel 82. In someembodiments, when the vascular access device is in an insertionconfiguration for insertion of the introducer needle 16 and catheter 12into the vein of the patient, the lower portion 42 b of the leading edge32 may be disposed distal to a primary bevel heel 84, which mayfacilitate introduction of the tip 14 into an incision made by theintroducer needle 16 prior to insertion of a full diameter of the needle16 into the incision. In these embodiments, in response to theintroducer needle 16 being inserted into the incision past the secondarybevel 82, no additional cutting of the skin may occur as the needle 16and the tip 14 are inserted into the vein of the patient. Instead, theskin may stretch over the tip 14 and/or the introducer needle 16 as acircumference of a widthwise cross-section of the needle 16 disposed inthe incision increases and the primary bevel 80 fully penetrates theincision. In some embodiments, the lower portion 42 b of the leadingedge 32 may be disposed between the primary bevel heel 84 and thesecondary bevel 82 in the insertion configuration, which may allow aportion of the tip 14 to be inserted into the incision withoutstretching the skin to a full or greatest outer diameter of theintroducer needle 16.

The asymmetric outer geometry may also improve insertion performance byreducing a lie distance, or a distance between the tip of the introducerneedle 16 and the lower portion 42 b of the leading edge 32, duringinsertion. For example, when the tip 44 of the introducer needle 16 isexposed from the tip 14 having the asymmetric outer geometry, the liedistance may equal a first distance 46. As illustrated in FIG. 3B, whenthe tip 44 of the introducer needle 16 is exposed from a tip 17 having asymmetric outer geometry, the lie distance may equal a second distance48. The first distance 46 may be less than the second distance 48. Areduced lie distance may improve a likelihood that the tip 14 is withinthe blood vessel 15 upon initial blood flashback and/or may reduce arisk of damaging or transfixing the blood vessel 15 during insertion ofthe introducer needle 16 and the tip 14 into the blood vessel 15.

These and other benefits of the asymmetric outer geometry may berealized when the tip 14 of the catheter 12 is inserted at a shallowangle through the patient's skin into the blood vessel 15 of thepatient. In further detail, after the catheter 12 is placed at a shallowangle into the blood vessel 15, a position of the tip 14 of the catheter12 relative to the blood vessel 15 may impact a fluid flow rate that canbe provided during infusion therapy and/or blood collection. A distallumen opening may be formed by a leading edge of the tip 14, such as,for example, the leading edge 32. Referring back to FIG. 1, because manyof the benefits of the asymmetric outer geometry may be realized whenthe tip 13 of the catheter 12 is inserted at the shallow angle into theblood vessel 15 of the patient, the PIVC 10 may include wings 60 or asecurement platform, which may aid a clinician in precisely manipulatingand controlling a position of the catheter 12 during venipuncture.

In some embodiments, the catheter 12 may include one or more flow holes62, each of which may extend through the outer wall 34 and the innerwall 28 at a predetermined bore angle. In some embodiments, one or moreof the flow holes 62 may be disposed in an upper side of the taperedportion 38, which may reduce direct impingement of infusates on thevenous wall and/or allow increased flow into the one or more flow holes62 during blood draw. The flow holes 62 may each include a passagewaythat includes an inner wall surface 65 defining a first plane. In someembodiments, an orientation of the first plane to the longitudinal axis30 may be acute. For example, the orientation of the first plane to thelongitudinal axis 30 may between about fifteen degrees and seventy-fivedegrees. In some embodiments, the orientation of the first plane to thelongitudinal axis 30 may be about forty-five degrees. In someembodiments, the bore angle of a particular flow hole 62 may be selectedso as to optimize flow efficiency through the particular flow hole 62and/or provide a flow path redundancy, reducing catheter tension withinthe vein, system pressure, and tip jet velocity.

In some embodiments, the flow holes 62 may generally be provided todivert fluid from the main channel of flow through the central lumen 26of the catheter 12. As such, the flow holes 62 may effectually slow thejet of infusant which issues from the tip 14 during infusion procedures.In some embodiments, the flow holes 62 may reduce exit velocity of aninfusant during infusion procedures, including rapid infusionprocedures. Additionally, the flow holes 62 may create a flow pathredundancy to relieve the overall pressure in the tip 14.

In these and other embodiments, the upper side of the tapered portion 38may include a single flow hole 62. In some embodiments, a large singleflow hole 62, as opposed to multiple smaller flow holes 62, may reduce arisk of blood clot formation and eventual occlusion of the single flowhole 62. In some embodiments, at least one third of a length of theupper side of the tapered portion 38 may include the single flow hole62.

One having skill in the art will appreciate that the number anddimensions of the flow holes 62 may be varied and adjusted to achieve adesired flow rate, a reduction in tip jet velocity, a reduction invascular damage, and/or increased bolus density. The one or more flowholes 62 may generally be provided by manufacturing methods known in theart. For example, in some embodiments the one or more flow holes 62 maybe provided with a laser drill.

Referring now to FIG. 4A, in some instances, when the tip 17 with asymmetric outer geometry is inserted in the blood vessel 15 of thepatient at the shallow angle, the distal lumen opening 58 of thecatheter 12 may be partially obstructed or blocked by the inner wall ofthe blood vessel 15 due to an angle of the distal lumen opening 58 withrespect to the inner wall of the blood vessel 15. For example, asillustrated in FIG. 4A, the angle of the distal lumen opening 58 of aparticular catheter 12 with a symmetric outer geometry may be less thanninety degrees with respect to the blood vessel 15, inhibiting flowthrough the distal lumen opening 58. In contrast, referring now to FIG.4B, the asymmetric outer geometry of the tip 14 may reduce obstructionor blocking of the distal lumen opening 58 of the catheter 12, which maybe oriented perpendicularly with respect to the inner wall of the bloodvessel 15 when the tip 14 is inserted in the blood vessel 15. As alsoillustrated in FIGS. 4A-4B, in some embodiments, the asymmetric outergeometry may increase a cross sectional area of the distal lumen opening58 of the catheter 12 and allow an increased flow rate through thedistal lumen opening 58. As illustrated in FIGS. 4A-4B, in someembodiments, the asymmetric outer geometry of the tip 14 may directinfusate towards a center of the blood vessel 15 compared to thesymmetric outer geometry of the tip 17.

Flow restriction, which may result from, for example, kinking, blockageof a particular catheter against the blood vessel 15, clotting, and/orother indwelling factors, may affect an ability of the clinician toobtain a sufficient amount of blood from the patient through theparticular catheter. Flow restriction may also result in hemolysis,impacting a quality of a blood sample. Referring now to FIGS. 5A-5B, theasymmetric outer geometry of the tip 14 may improve line draw successand/or reduce hemolysis of blood samples collected using the tip 14 ascompared to the tip 17.

For example, as illustrated in FIGS. 5A-5B, the asymmetric outergeometry of the tip 14 may reduce obstruction or blocking of the distallumen opening 58 of the catheter 12 by the blood vessel 15 and/orincrease the cross sectional area of the distal lumen opening 58,lowering localized pressure at the tip 14 during blood collection.Furthermore, the flow holes 62 may provide a flow path redundancy and/ormay allow blood to be collected more rapidly. As mentioned, in someembodiments, a large single flow hole 62, as opposed to multiple smallerflow holes 62, may reduce a risk of blood clot formation and eventualocclusion of the single flow hole 62. The asymmetric outer geometry ofthe tip 14, as compared with the symmetric outer geometry of the tip 17,may place the distal lumen opening 58 into a position and angle similarto a needle-based blood draw system and position the distal lumenopening 58 further away from the wall of the blood vessel 15.

In some embodiments, the tip 17 may exhibit catheter penetration forcepeaks of similar or greater magnitude as compared with cannulapenetration force peaks, while the asymmetric outer geometry of the tip14 may provide spatial and temporal distribution of contact between theleading edge 32 of the tip 14 and the skin and/or blood vessel 15 of thepatient, which may lower a magnitude and broaden a width of the catheterpenetration force peak. In some embodiments, the tapering of the upperportion and/or the lower portion 42 b (illustrated in FIG. 10) mayreduce the penetration force by reducing surface area of the tip 14normal to the skin and/or the blood vessel 15.

Referring back to FIG. 2, in some embodiments, the catheter 12 may havean internal geometry defined by the inner wall 28. For example, theinner wall 28 may include a distal land portion 64, a proximal portion66, and a shoulder 68 connecting the land portion 64 and the proximalportion 66. A diameter 69 of the land portion 64 may be slightly lessthan a diameter of the introducer needle 16 near the tip 44 of theintroducer needle 16 such that there is a friction fit between the landportion 64 and the introducer needle 16. Thus, in some embodiments, theland portion 64 of the tip 14 may conform tightly to the outer surfaceof the introducer needle 16.

In some embodiments, the land portion 64 may extend from the leadingedge 32 to the shoulder 68. In some embodiments, the land portion 64 maybe asymmetric. For example, a proximal end 70 a of one side of the landportion 64 may be offset from a proximal end 70 b of an opposite side ofthe land portion 64, such that the two proximal ends 70 a, 70 b are notdiametrically opposed. In some embodiments, a cross-section of the landportion 64 may have a shape of a parallelogram, as illustrated in FIG.2. In some embodiments, the proximal end 70 b, which may be disposed ona lower side of the land portion 64, may be disposed distally to theproximal end 70 a, which may be disposed on an upper side of the landportion 64. In some embodiments, the land portion 64 may be terminatedby the leading edge 32.

In some embodiments, a portion of the inner wall 28 corresponding to anupper edge 72 of the shoulder 68 may be disposed at an angle withrespect to the longitudinal axis 30. Additionally or alternatively, insome embodiments, a portion of the inner wall 28 correspond to a loweredge 74 of the shoulder 68 may be disposed at an angle with respect tothe longitudinal axis 30. For example, the upper edge 72 may be disposedat an angle of between about 10 degrees and 80 degrees with respect tothe longitudinal axis 30. For example, the lower edge 74 may be disposedat an angle of between about 10 degrees and 80 degrees with respect tothe longitudinal axis 30. In some embodiments, the upper edge 72 may bemore angled than the lower edge 74 with respect to the longitudinal axis30. In some embodiments, a cross-section of the shoulder 68 may have ashape of a quadrilateral.

In some embodiments, the shoulder 68 may be asymmetric. For example, aproximal end 76 of the upper edge 72 may be offset from a proximal end78 of the lower edge 74, such that the proximal end 76 of the upper edge72 and the proximal end 78 of the lower edge 74 are not diametricallyopposed. In these embodiments, a straight line segment extending fromthe proximal end 76 of the upper edge 72 to a proximal end 78 of thelower edge 74 may not be normal to the longitudinal axis of the catheter12. Additionally or alternatively, in some embodiments, a distal end ofthe upper edge 72, which may correspond to the proximal end 70 a of theland portion 64, may be offset from a distal end of the lower edge 74,which may correspond to the proximal end 70 b of the land portion 64,such that the distal end of the upper edge 72 and the distal end of thelower edge 74 are not diametrically opposed.

The tip 14 having an asymmetric shoulder 68 and/or an asymmetric landportion 64 may affect flow dynamics within the tip 14 by, for example,directing flow through the flow hole 62 illustrated in FIG. 2 and/orother flow holes 62.

In some embodiments, the passageway of each of the one or more of theflow holes 62 may extend through the land portion 64. In someembodiments, the passageway of one or more flow holes 62 may extendthrough an upper side of the land portion 64 and/or an upper side of thetapered portion 38. In some embodiments, the one or more flow holes 62may be disposed in the land portion 64 to prevent blood from exiting theone or more flow holes 62 during insertion. In further detail, in someembodiments, the notch adjacent to the tip 44 or distal end of theintroducer needle 16 may be disposed proximal to a portion of theintroducer needle 16 that contacts the land portion when the introducerneedle 16 and the catheter 12 are inserted into the blood vessel 15 ofthe patient.

Referring now to FIG. 6, in some embodiments, a tip 19 may have anasymmetric outer geometry formed by the outer wall 34 and a symmetricinner geometry formed by the inner wall 28. For example, the proximalend 70 a of one side of the land portion 64 may be aligned with theproximal end 70 b of an opposite side of the land portion 64, such thatthe two proximal ends 70 a, 70 b are diametrically opposed, asillustrated in FIG. 6. In these embodiments, a straight line segmentextending from the proximal end 76 of the upper edge 72 to a proximalend 78 of the lower edge 74 may be normal to the longitudinal axis ofthe catheter 12. In some embodiments, the tip 19 may correspond to thetip 13 of FIG. 1 or the tip 14 of FIG. 2. In some embodiments, theproximal end 70 b, which may be disposed on a lower side of the landportion 64, may be disposed distally to the proximal end 70 a, which maybe disposed on an upper side of the land portion 64. In someembodiments, the inner geometry of the tip 14 may be symmetric exceptfor presence of the one or more flow holes 62 disposed in the upper sideof the tapered portion 38, which may be absent from the lower side ofthe tapered portion 38. In some embodiments, the one or more flow holes62 may be disposed in the upper side of the tapered portion 38 and/orthe lower side of the tapered portion 38.

FIGS. 7-8 are now referred to, which illustrate a circular flow hole 62.However, in some embodiments, one or more of the flow holes 62 may benon-circular. A circular flow hole 62 may issue a substantiallycylindrical jet of fluid into the vasculature of a patient. In general,the substantially cylindrical jet may be concentrated and direct andbreak up slowly within the vein. It follows that a non-circular flowhole 62 (not illustrated) may issue a jet of fluid having asubstantially non-circular cross section, and thus greater surface area.The increase in surface area of the jet issuing from the non-circularflow hole 62 may increase a rate of momentum transfer between the jetand the intravenous environment compared to that of more cylindrical jetof FIG. 7. Thus, the jet issuing from the non-circular flow hole 62 maydisperse and decelerate more quickly, posing less of a threat ofextravasation to vein walls.

Referring now to FIG. 8, in some embodiments, the leading edge 32 of aparticular catheter tip with an asymmetric outer geometry, such as, forexample, the tip 14 of FIG. 2 or the tip 19 of FIG. 6, may form acircle, an ellipse, or another shape. In some embodiments, a linesegment extending from the upper portion 42 a to the lower portion 42 bof the leading edge 32 may not be normal to the longitudinal axis of thecatheter 12 and/or the needle 16. As illustrated in FIG. 8, in someembodiments, the leading edge 32 of the particular catheter tip may forman ellipse. In contrast, the leading edge 32 of the tip 17, which mayinclude a symmetric outer geometry as illustrated, for example, in FIG.4A, may form a circle, which may lie in a plane normal to thelongitudinal axis of the catheter 12.

Referring now to FIG. 9, in some embodiments, the shoulder 68 may beasymmetric and annular. A particular shoulder 68 that is symmetric mayalso be annular.

Referring now to FIG. 10, in some embodiments, the tip 86 may correspondto the tip 13, the tip 14, or the tip 19 of the previous Figures. Insome embodiments, the outer geometry of the tip 86 may facilitateintroduction of the catheter 12 into the incision made by the needle 16.In further detail, in some embodiments, a first upper portion 100 of thetapered portion 38 and/or a first lower portion 102 of the taperedportion 38 may be tapered at an angle between 10 and 45 degrees withrespect to the longitudinal axis of the catheter 12. In someembodiments, the first upper portion 100 and/or the first lower portion102 may be tapered with respect to the longitudinal axis of the catheter12 at same or different angles from each other.

In some embodiments, a second upper portion 104 of the tapered portion38 and/or a second lower portion 106 of the tapered portion 38 may betapered at an angle between 2 and 30 degrees with respect to thelongitudinal axis of the catheter 12. In some embodiments, the secondupper portion 104 and/or the second lower portion 106 may be taperedwith respect to the longitudinal axis of the catheter 12 at same ordifferent angles from each other.

In some embodiments, a radial height of the tapered portion 38 may beuniform or variable around a particular circumference of the taperedportion 38. In some embodiments, a radial height 88 of the first upperportion 100 and/or a radial height 90 of the first lower portion 102 maybe between 0.0005 and 0.003 inches. In some embodiments, the radialheight 88 of the first upper portion 100 may be different from theradial height 90 of the first lower portion 102. In some embodiments,the radial height 88 of the first upper portion 100 may be the same asthe radial height 90 of the first lower portion 102.

In some embodiments, the first upper portion 100 may be tapered at anangle greater than the second upper portion 104 with respect to thelongitudinal axis of the catheter 12, which may facilitate introductionof the catheter 12 into the incision made by the needle 16. Additionallyor alternatively, in some embodiments, the first lower portion 102 maybe tapered at an angle greater than the second lower portion 106, whichmay facilitate introduction of the catheter 12 into the incision made bythe needle 16.

Referring now to FIGS. 11A-11B, in some embodiments, the tapered portion38 of a catheter tip 92 of the catheter 12 may be non-linearly taperedor curved. In some embodiments, the tip 92 may correspond to the tip 13,the tip 14, or the tip 19 of the previous Figures. Referring now toFIGS. 12A-12C, in some embodiments, a radius of the tapered portion 38may decrease linearly along an entire length of the tapered portion 38to the leading edge 32. In some embodiments, the leading edge 32 may beplanar.

Referring now to FIGS. 13A-13B, in some embodiments, the leading edge 32of a catheter tip 96 of the catheter 12 may be beveled between the upperand lower portions 42 a, 42 b at an angle. In some embodiments, theleading edge 32 may be beveled between the upper and lower portions 42a, 42 b at an angle between 30 and 80 degrees with respect to thelongitudinal axis of the catheter 12. As illustrated in FIGS. 13A-13B,in some embodiments, the leading edge may be beveled between the upperand lower portions 42 a, 42 b at an angle of 45 degrees with respect tothe longitudinal axis of the catheter 12. In some embodiments, theellipse formed by the leading edge 32 may lie in a single plane, as inFIGS. 13A-13B. The ellipse and/or the single plane may decreaseresistance to penetration and/or prevent “peel back” upon insertion ofthe particular catheter tip. In some embodiments, the single plane maynot be normal to the longitudinal axis of the catheter 12 and/or theneedle 16. In some embodiments, the tip 96 may correspond to the tip 13,the tip 14, the tip 19, or the tip 92 of the previous Figures.

Referring now to FIG. 14, in some embodiments, the leading edge 32 of acatheter tip 98 may be beveled between the upper and lower portions 42a, 42 b at an angle of 60 degrees with respect to the longitudinal axisof the catheter 12. In some embodiments, the tip 98 may correspond tothe tip 13, the tip 14, the tip 19, or the tip 92 of the previousFigures. In some embodiments, the tip 96 may correspond to the tip 13,the tip 14, the tip 19, the tip 92, or the tip 96 of the previousFigures.

One of skill in the art will appreciate the possible variations andspecific features of available vascular access devices, including thePIVC 10 and/or the catheter 12, as are commonly used in the medical andresearch professions. For example, in some embodiments the PIVC 10 inaccordance with the present invention may include additional accesssites, clamps, parallel intravenous lines, valves, couplers, introducerneedles, coatings, and/or materials as desired to fit a specificapplication.

Referring now to FIG. 15, in some embodiments, at least a portion of theleading edge 32 of a catheter tip 110 may be beveled. In someembodiments, a distal portion of the leading edge 32 may be normal withrespect to the longitudinal axis 32, while a proximal portion of theleading edge 32 may be beveled at various angles, such as, for example,between 20 and 80 degrees with respect to the longitudinal axis. Thisangle is shown at “A” on FIG. 15. In some embodiments, the proximalportion of the leading edge 32 may be normal with respect to thelongitudinal axis 32, while the distal portion of the leading edge 32may be beveled at various angles, such as, for example, between 20 and80 degrees with respect to the longitudinal axis.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

The invention claimed is:
 1. A catheter, comprising: a catheter body,wherein the catheter body comprises a proximal end, a distal end, and alumen formed by an inner wall of the catheter body that extends betweenthe proximal end and the distal end along a longitudinal axis, whereinthe distal end comprises: a distal lumen opening disposed on thelongitudinal axis; and a beveled leading edge forming a distalmostsurface of the catheter body and having no more than one openingextending therethrough, wherein the beveled leading edge forms thedistal lumen opening, wherein the beveled leading edge comprises anupper portion and a lower portion, wherein the upper portion and thelower portion are disposed on opposite sides of the distal lumenopening, wherein the lower portion is disposed distal to the upperportion; and a fluid flow path extending from the beveled leading edgethrough a proximal end of the catheter body, wherein the inner wall ofthe catheter body comprises a land portion at least proximate thebeveled leading edge, wherein a cross-section of the land portion isconfigured in a shape of a parallelogram, wherein the inner wall of thecatheter body further comprises a shoulder proximate to the landportion, wherein a portion of the inner wall corresponding to an upperedge of the shoulder is angled with respect to the longitudinal axis,wherein a portion of the inner wall corresponding to a lower edge of theshoulder is angled with respect to the longitudinal axis, wherein adistal end of the upper edge of the shoulder is offset from a distal endof the lower edge of the shoulder.
 2. The peripheral catheter of claim1, wherein an outer wall of the catheter body comprises a taperedportion, wherein the tapered portion is disposed at least proximate thebeveled leading edge.
 3. The peripheral catheter of claim 2, an upperside of the tapered portion includes one or more flow holes, wherein theone or more flow holes are in communication with the lumen, wherein theone or more flow holes each include a passage way having an inner wallsurface defining a first plane, wherein an orientation of the firstplane to the longitudinal axis is acute.
 4. The peripheral cathetersystem of claim 1, wherein the beveled leading edge is beveled betweenthirty degrees and eighty degrees with respect to the longitudinal axis.5. The peripheral catheter system of claim 1, wherein an outer wall ofthe catheter body comprises a tapered portion and an untapered portion,wherein the tapered portion is disposed at least proximate the beveledleading edge.
 6. The peripheral catheter system of claim 5, wherein thetapered portion tapers inwardly at an angle between two and thirtydegrees with respect to the longitudinal axis.
 7. The peripheralcatheter system of claim 5, wherein an upper side of the tapered portionincludes a flow hole, wherein the flow hole is in communication with thelumen, wherein the flow hole includes a passage way having an inner wallsurface defining a first plane, wherein an orientation of the firstplane to the longitudinal axis is acute.
 8. The peripheral cathetersystem of claim 7, wherein the orientation of the first plane to thelongitudinal axis is forty-five degrees.